# K171526: Zenius™, lliad™ and Kora™ Spinal Fixation Systems

- Pathway: 510(k) (Traditional)
- Applicant: Medyssey USA, Inc.
- Decided: Aug 21, 2017 after 88 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K990745 (1999). 109 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 112 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121670: Medyssey Cannulated Pedicle Screw, Medyssey Co, Ltd. (2013) Summary page 4.
- K093104: Medyssey CO., LTD., Zenius Spinal System, Medyssey Co, Ltd. (2010) Summary page 4.
- K103272: Zenius Spinal System, Medyssey Co, Ltd. (2010) Summary page 4.
- K081153: Novel Spinal System, Medyssey Co, Ltd. (2009) Summary page 4.
- K103147: Novel Iii Spinal Fixation and Adjustable Bridge System, Medyssey Co, Ltd. (2010) Summary page 4.
- K110284: Novel Iii Spinal Fixation and Adjustable Bridge System, Medyssey Co, Ltd. (2011) Summary page 4.

## Most influential descendants
- K232218: Zenius™ Spinal System (2023), 0 descendants of its own
- K181978: Zenius™, Iliad™ and Kora™ Spinal Fixation Systems (2018), 0 descendants of its own

## Indications for use
The Medyssey Co, Ltd. Zenius™, lliad™ and Kora™ Spinal Fixation Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K171526
Methodology: https://510kreport.com/methodology